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Nov 13, 2008 9:16 pm US/Central

2 Investigators: Formula For Tragedy

Powdered Baby Formula Could Be Dangerous For Some Infants

  Dave Savini

CHICAGO (CBS) ― A warning for parents: Milk-based powdered formula  
could put premature babies at risk.

And it is a possible cause for the death of an infant born at Rush- 
Copley Medical Center in Aurora and other babies across the country.

Connor McGray and his twin brother, Logan, were born prematurely on  
Nov. 16, 2007, at Rush-Copley.

Connor appeared to be the healthier of the two — until a week later  
when their parents, Amanda Carlin and Tim McGray of Somonauk, received  
a call from a doctor at the hospital, saying the infant was lethargic  
and refusing to eat.

Doctors discovered Connor had meningitis, McGray said, and "they  
basically told us, all we could do (was) pray."

The baby died at home on May 3, 2008, five months after he was born.
The cause of death listed on the baby's death certificate is  
hydrocephalus and bacterial meningitis. The bacterial infection,  
according to a memo from the Illinois Department of Public Health,  
"may be associated with the consumption of a powdered breast milk  
fortifier."

The Enfamil brand powdered formula was fed to the baby while he was  
being cared for in the Neo-Natal Intensive Care Unit at Rush-Copley.
In a statement released Thursday, Rush-Copley said, "We have the  
utmost compassion for the baby and his family.

"Rush-Copley delivers 4,000 babies a year and the procedures followed  
here are consistent with the standards of care provided to prematurely  
born infants in the U.S."

The danger with powdered formula is that, unlike the liquid kind, it  
cannot be sterilized, making it vulnerable to bacteria growing in it,  
according to the Centers for Disease Control and Prevention.

The most severe cases involve babies exposed to a bacteria called  
Enterobacter sakazakii, or E-sak, which can lead to raging infections,  
severe brain damage, and ultimately death, according to the CDC.
Amanda Carlin said son Connor died after the E-sak bacteria led to an  
infection which caused the deadly form of meningitis.

The baby suffered from seizures and brain abscess. And his blood and  
cerebral spinal fluid tested positive for the organism, the Health  
Department document says.

During the week before Connor's illness, the Health Department memo  
says, he was fed ready-to-feed liquid formula as well as breast milk  
with powdered infant fortifier.

The powdered formula used by the hospital was Enfamil by Mead Johnson.  
Connor consumed the product from Nov. 20 through Nov. 24 orally and  
through a nasogastric tube, the Health Department says. The report  
said the product was prepared at the hospital in a prep area/station,  
not a dedicated formula preparation room.

On Dec. 3, 2007, Connor was transferred from Rush-Copley to the  
University of Chicago because, McGray said, the family wanted the twin  
boys together. Logan was being treated at the University of Chicago  
for an intestinal condition.

Infants born prematurely, or those with weak immune systems, are at  
greatest risk of being infected, according to the U.S. Department of  
Health and Human Services. There is even a warning on powdered formula  
containers. One brand warns: "... powdered infant formulas are not  
sterile and should not be fed to premature infants or infants who  
might have immune problems unless directed and supervised by your  
baby's doctor."

Carlin said the hospital did not tell her about the risks of powdered  
formula. She said she also didn't learn about her son being given the  
powder, until she hired The Collins Law firm in Naperville.

"We didn't find out until afterward, when we got a hold of whatever  
medical records we could get," McGray said. "That's the only way we  
knew."

A CBS2/Beacon News investigation uncovered other cases in which  
powdered formula was blamed for causing brain damage or death in  
infants. There have been at least two Illinois cases, and cases in at  
least 17 other states.

"It's not an isolated problem," said Ed Manzke, one of the attorneys  
hired in Connor McGray's case. "There have been deaths all across the  
country related to powder infant formulas. And what is so shocking  
about it, is hardly anyone knows it."

A 2001 E-Sak outbreak in Tennessee led to a 2002 U.S. Food and Drug  
Administration warning to health professionals. In a letter the FDA  
wrote: ".. FDA recommends that powdered infant formulas not be used in  
neonatal intensive care settings unless there is no alternative  
available."

The FDA also said there are sterilized liquid fortifiers on the market  
that can be used as an alternative. The FDA would not put a complete  
ban on the powder and said it may be used in the NICU when no  
appropriate liquid product is available.

Five years after this FDA warning, Connor McGray was given the  
powdered formula, according to the Health Department document.
His family says he was getting stronger and doing well until he got  
the powder.

Similar to Connor, Daniel Korte was born prematurely last year. He,  
too, was fed powdered infant formula and was struck with the same  
infection and meningitis. His parents said the contaminated formula  
was fed to him at Mercy Medical Center in Des Moines, Iowa.

Daniel survived, but is living in a nursing facility on a ventilator.
"It basically turned his brain to mush," said Michelle Korte, Daniel's  
mother. "He is ventilated and his upper brain is destroyed."

Korte said the hospital in this case also never warned her about the  
risk associated with the formula. An attorney she hired, Andy  
Weisbecker, said powdered formula manufacturers need to do a better  
job of informing doctors and parents about the danger.

"More needs to be done to increase the level of knowledge about this  
deadly bug," Weisbecker said. "Who knows how many parents are out  
there with affected children who may still not be aware of a possible  
connection between these illnesses and contaminated formula."

Federal regulators believe the number of cases are under-reported.  
There may be other infants diagnosed with meningitis that have not  
been checked for E-sak.

Babies are not just being sickened by formula in hospitals, however.  
Parents unknowingly are buying the powdered formula for at-risk babies.
Stephen Meyer, an attorney at the Law Office of Nick Stein in Indiana,  
has spent nine years working on E-sak cases. He said the FDA's warning  
should have gone to consumers.

"Most moms would think 'If it's marketed to me, it's safe,'" said  
Meyers. "Especially if it comes in a hospital gift bag."

Mead Johnson, manufacturer of powdered formula including Enfamil, said  
its products are safe as long as they are used according to label  
directions. The company said it has "taken the position that powdered  
infant formula should not be used in neonatal intensive care settings  
unless no alternative is available."

Tracey Noe, a spokesman for Abbott, which manufactures formula  
including Similac, said it uses rigorous testing procedures, including  
bacterial testing, on its powdered formulas.

"Abbott agrees with the U.S. Food and Drug Administration/Centers for  
Disease Control and Prevention joint recommendation that powdered  
formula should not be used in hospital neonatal intensive care units  
— unless no nutritionally suitable alternative is available," Noe  
said.
Both manufacturers have been sued by formula victims.

The parents of Connor McGray and Daniel Korte are also planning to  
file lawsuits. In the meantime they are talking about what happened in  
hopes of warning — and educating — doctors, hospital staff and  
other parents about the potential danger of powdered formula.

"I want other people to be aware of it so they don't have to go  
through what I did," Amanda Carlin said.

Christine Moyer of the Aurora Beacon News and Michele Youngerman and  
Michelle Diotallevi of CBS2 contributed to this report.

http://cbs2chicago.com/local/baby.formula.tainted.2.863980.html

------------------------------------------
Naomi Bar-Yam Ph.D.
Executive Director
Mothers' Milk Bank of New England

[log in to unmask]
617-964-6676
www.milkbankne.org
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